Novel powered 5.0-mm endoscopic debridement catheter for endoscopic transmural necrosectomy of pancreatic walled-off necrosis: a case series of consecutive patients from a tertiary referral center (with video).

BACKGROUND AND AIMS: EUS-guided drainage and, if required, endoscopic necrosectomy (EN) has become the criterion standard for the treatment of pancreatic walled-off necrosis (WON). A dedicated powered endoscopic debridement system, the EndoRotor (Interscope Inc, Northbridge, Mass, USA), has been introduced as an alternative to snare necrosectomy. This study evaluates the novel EndoRotor catheter, NecroMax 6.0 (Interscope Inc, Whitinsville, Mass, USA), for EN in patients with WON. METHODS: This single-center retrospective case series included consecutive patients with WON treated with the NecroMax 6.0 catheter. Safety, ability to perform EN, and clinical resolution were evaluated. RESULTS: Twenty patients underwent 30 EN procedures with the NecroMax 6.0 catheter. One suspected device-related adverse event was observed (3.3%). In 1 procedure, EN could not be performed because of excessive bending of the endoscope. Eighteen patients (90.0%) achieved clinical resolution. CONCLUSIONS: EN with the NecroMax 6.0 catheter was technically feasible in 96.7% of patients with a low rate of adverse events.

EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial.

OBJECTIVE: In treating pancreatic walled-off necrosis (WON), lumen-apposing metal stents (LAMS) have not proven superior to the traditional double pigtail technique (DPT). Among patients with large WON (>15 cm) and their associated substantial risk of treatment failure, the increased drainage capacity of a novel 20-mm LAMS might improve clinical outcomes. Hence, we conducted a study comparing the DPT and 20-mm LAMS in patients with large WON. DESIGN: A single-centre, open-label, randomised, controlled superiority trial using an endoscopic step-up approach in patients with WON exceeding 15 cm in size. The primary endpoint was the number of necrosectomies needed to achieve clinical success (clinical and CT resolution), while the secondary endpoints included technical success, adverse events, length of stay and mortality. RESULTS: Twenty-two patients were included in the DPT group and 20 in the LAMS group, with no significant differences in patient characteristics. The median size of WON was 24.1 cm (P25-P75: 19.6-31.1). The technical success rates were 100% for DPT and 95% for LAMS (p=0.48), while clinical success rates were 95.5% and 94.7%, respectively (p=1.0). The mean number of necrosectomies was 2.2 for DPT and 3.2 for LAMS (p=0.42). Five patients (12%) developed procedure-related serious adverse events (DPT=4, LAMS=1, p=0.35). The median length of stay was 43 (P25-P75: 40-67) and 58 days (P25-P75: 40-86) in the DPT and LAMS groups (p=0.71), respectively, with an overall mortality of 4.8%. CONCLUSIONS: For treating large WON, LAMS are not superior to DPT. The techniques are associated with comparable needs for necrosectomy and hospital stay, and no gross difference in adverse events. TRIAL REGISTRATION NUMBER: NCT04057846.

Validation of the Endoscopic Part of the Spigelman Classification for Evaluating Duodenal Adenomatosis in Familial Adenomatous Polyposis: A Prospective Study of Interrater and Intrarater Reliability.

INTRODUCTION: In patients with familial adenomatous polyposis, the Spigelman classification is recommended for staging and risk stratification of duodenal adenomatosis. Although the classification has been used for decades, it has never been formally validated. METHODS: We included consecutive FAP patients undergoing upper gastrointestinal endoscopic surveillance and evaluated the inter- and intrarater reliability of the Spigelman classification. RESULTS: The interrater reliability of the endoscopic parameters and the Spigelman classification was good and excellent, respectively. The intrarater reliability of the endoscopic parameters and the Spigelman classification was moderate and good, respectively. DISCUSSION: The results support continued use of the Spigelman classification as the primary end point for future studies and as key endoscopic performance measure.

Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: Retrospective, single tertiary center cohort study.

OBJECTIVE: Acute pancreatitis with walled-off necrosis (WON) is associated with considerable morbidity and mortality. Previous studies have evaluated outcomes in WON collections of limited size, while data about large WON with long-term follow-up are lacking. We aimed to report our experience in managing large WON. METHODS: Between 2010 and 2020, consecutive patients with large (>15 cm) WON were identified from a prospectively maintained database. Patients with chronic pancreatitis or an index intervention 90 days or more from the debut of symptoms were excluded. We registered clinical and technical outcomes following minimally invasive treatment in WON >15 cm. Follow-up was a minimum of 1 year. RESULTS: Overall, 144 patients with WON >15 cm, with a median age of 60 (interquartile range [IQR] 49-69) years, were included. The median WON size was 19.2 cm (IQR 16.8-22.1). Most patients were treated with endoscopic transluminal drainage (93%). The median length of stay was 53 days (IQR 39-76) and 61 (42%) patients needed intensive care support during their hospital stay. As 143 patients (99%) were managed using endoscopic or video-assisted retroperitoneal techniques, only one (0.7%) patient needed an open necrosectomy. Procedure-related adverse events occurred in 10 (7%) patients. Overall, 24 patients (17%) died during admission, all due to multiorgan failure. The median follow-up was 35 months (IQR 15-63.5). Complete resolution was achieved in all remaining patients. CONCLUSION: Minimally invasive treatment of large WON is feasible, with a minimal need for surgery and acceptable rates of morbidity and mortality.

Colorectal Cancer in Individuals With Familial Adenomatous Polyposis, Based on Analysis of the Danish Polyposis Registry.

BACKGROUND & AIMS: Familial adenomatous polyposis (FAP) is an autosomal dominant disorder that increases risk for colorectal cancer (CRC). We assessed changes in the incidence and prevalence of CRC, and survival times, of patients with FAP participating in the Danish follow-up study. METHODS: We collected data from the Danish Polyposis Registry, a nationwide, complete registry of patients with FAP that includes clinical information, surgical procedures, follow-up findings, and pathology reports. We compared data between the periods of 1990-1999 and 2000-2017. In 2017, the registry contained 226 families with 721 individuals with FAP. Probands were defined as patients diagnosed based on bowel symptoms, without any knowledge of hereditary bowel disease. Call-up patients were defined as those found to have FAP during screening and due to a diagnosis of FAP in first-degree relatives. RESULTS: Although the mean incidence rate of FAP was stable from 1990-1999 (0.19/100,000/year) to 2000-2017 (0.32/100,000/year) (P = .91), the point prevalence increased from 4.86/100,000 in 1999 to 6.11/100,000 by the end of 2017 (P = .005). During 2000-2017, 25 of 72,218 CRC cases were associated with FAP (0.03%)-this was a significant decrease from 1990-1999 (26/30,005 cases; 0.09%) (P = .001). The risk of CRC was significantly higher for probands (n = 191; 61.6%) than call-up cases (n = 5; 1.9%) (P < .001). All CRCs in call-up patients were detected at the diagnosis of FAP (no cases were identified in the follow-up program). The median life expectancy for call-up patients was 72.0 years (95% CI, 63.3-80.7), compared to 55.0 years for probands (95% CI, 51.2-58.8) (P < .001). Therefore, the tracing and follow-up program increased life expectancy by 17.0 years for first-degree family members. CONCLUSION: The Danish Polyposis Registry enables close monitoring of patients with FAP, reducing risk of CRC and prolonging life.

The cost of endoscopic treatment for walled-off pancreatic necrosis.

BACKGROUND: Use of minimally invasive techniques has reduced mortality in walled-off pancreatic necrosis (WON) but may be costly. The aim of this study was to evaluate the actual costs associated with the endoscopic management of patients with WON. METHODS: We included a retrospective cohort of WON patients treated with endoscopic, transgastric drainage and necrosectomy (ETDN) during 2013-2014. Costs were calculated for six sub-areas based on a micro-costing model. Students T-test and non-parametric analysis of variance were performed to evaluate costs in relation to disease etiology and outcome. RESULTS: We included 58 patients (50% men, median age 57 years). The most common etiologies were gallstones (57%) and alcohol (19%). Nine patients (16%) died during admission. The median length of stay was 50 days (IQR 31 days). Eighteen patients (31%) needed treatment in our intensive care unit with a median length of stay of 16 days (IQR 31 days). The mean costs and standard deviation of costs (SD) per patient were: diagnostic imaging $2,431 ($2,301), laboratory tests $3,579 ($2,477), blood products $982 ($1,734), endoscopic treatment $3,794 ($1,777), medicine $5,440 ($6,656), and ward cost $41,260 ($35,854). The mean total cost was $57,486 ($46,739). Post-ERCP pancreatitis and mortality predicted higher costs. CONCLUSIONS: This study sheds light on the different costs associated with endoscopic treatment of WON. As nearly three quarters of the costs are related to ward care, initiatives aimed at reducing the length of hospital stay may have a great impact on making endoscopic treatment more cost effective.

Evaluation of local instillation of antibiotics in infected walled-off pancreatic necrosis.

BACKGROUND: Infected walled-off pancreatic necrosis (WON) is associated with increased morbidity and mortality. Systemic antibiotics are the main treatment, but are associated with adverse reactions and risk of superinfections. This study evaluates the efficacy of local instillation of antibiotics into WON. METHODS: We performed a retrospective cohort study of all consecutive patients with infected WON, who were treated with endoscopic transmural drainage and necrosectomy (ETDN) at a tertiary referral hospital between 2012 and 2016. A total of 91 patients were included. Patients often received concomitant intravenous and local antibiotics. Local antibiotics were added to the irrigation fluid depending on microbiological findings. A beneficial response was defined as the eradication of a microbe on subsequent culturing. Univariable and multivariable logistic regression analyses were used to evaluate antimicrobial efficacy. RESULTS: At the first drainage 81 (86%) patients had infected and 10 sterile WON. Among patients with bacterial infections, neither local nor systemic antibiotics were associated with the eradication of microbes between first and second culture. Between the second and third culture, the use of local antibiotics was associated with the eradication of microbes (OR, 2.54; 95% CI, 1.25-5.18; p = 0.01), but not systemic antibiotics (OR, 0.75; 95% CI, 0.38-1.38; p = 0.33). Twelve patients had fungal infections treated with local amphotericin B between first and second culture. The fungus was eradicated in all 12 patients. CONCLUSION: Local instillation of antibiotics may be a promising supplement to systemic administration.

Extracorporeal shock wave lithotripsy for pancreatic duct stones: an observational study.

INTRODUCTION: Previous studies suggest that fragmentation of pancreatic duct stones (PDS) using extracorporeal shock wave lithotripsy (ESWL) is associated with pain relief. However, the treatment may not be effective in certain subgroups. AIM: To evaluate predictors of pain relief after ESWL in patients with chronic pancreatitis and PDS. METHODS: Retrospective study including patients with chronic pancreatitis undergoing ESWL for painful PDS. Analgesic use before and after the ESWL procedure was registered. We defined adequate pain relief after ESWL as 'pain-free without analgesics or with use of weak analgesics as needed'. The study was approved by the Danish Data Protection Agency (approval number: AHH-2017-048). RESULTS: We included 81 patients (median age 58 years; 63% men; 68% alcoholic pancreatitis). Patients underwent one to seven ESWL procedures (mean 1.7). A concurrent ERCP was performed in 17%. All patients used analgesics before the ESWL procedure (68 used opioids). After ESWL, 43 still used opioids. Thirty-two patients achieved adequate pain relief. Univariable regression analysis showed that older age predicted adequate pain relief (OR 1.09;1.03-1.16; p = .002) as did location of the stone in the head or neck (OR 2.59;1.04-6.45; p = .041). In multivariable analysis, we found that the only two predictors of adequate pain relief were age (p = .002) and the location of the stones (p = .039). CONCLUSION: After the ESWL, about four out of ten patients are pain-free without medication or able to manage their pain with weak analgesics. Age and the location of the stones may be considered when evaluating if patients are eligible for referral to ESWL.

Endoscopic Necrosectomy Through Percutaneous Self-Expanding Metal Stents May Be a Promising Additive in Treatment of Necrotizing Pancreatitis.

BACKGROUND: The recommended treatment of infected walled-off necrosis (WON) in necrotizing pancreatitis entails a step-up treatment approach starting with endoscopic necrosectomy (ETDN). AIMS: To report a small number of cases from 2013 to 2016 that were not amenable to or failed to respond to ETDN, and to describe a new, minimally invasive technique that may be a promising supplement to ETDN in this difficult patient population. METHODS: Using the Seldinger technique, a fully covered self-expanding metal stent (SEMS) was placed percutaneously in order to drain, irrigate, and debride WON. After resolution, the stent was removed. We reviewed electronic patient records and defined clinical success as complete WON resolution with removal of internal as well as percutaneous drains and stents. RESULTS: Five patients underwent treatment with SEMS placement. The mean length of the WON was 33.4 cm. Clinical success was achieved in four patients after an average of 5.75 necrosectomy sessions. One patient died from severe sepsis. Adverse events included severe abdominal pain and productive cutaneous fistulae (two patients). CONCLUSIONS: In our small case series, endoscopic necrosectomy through a percutaneous SEMS seemed beneficial and safe in the treatment of infected WON.

Endoscopic, transmural drainage and necrosectomy for walled-off pancreatic and peripancreatic necrosis is associated with low mortality--a single-center experience.

OBJECTIVE: Endoscopic transmural drainage and necrosectomy (ETDN) is a promising alternative to percutaneous drainage and surgical intervention in the treatment of walled-off pancreatic and peripancreatic necroses (WONs). We assessed the outcome and safety profile of ETDN in a single-center patient cohort. MATERIALS AND METHODS: In November 2005, ETDN for WON was introduced in our tertiary referral center. During a 6-year period (Nov 2005-Nov 2011), we retrospectively collected data on all patients who underwent ETDN. RESULTS: Eighty-one patients were treated with ETDN (median age 54, 52 men). Gallstones were the predominant etiology of pancreatitis (41%), followed by alcohol (33%). Median time from debut of symptoms to first endoscopic treatment was 44 (9-246) days. Culture-proven infected necrosis was found in 71% of the cases. Twenty-three patients (28%) required admission in intensive care unit. The technical and clinical success rates were 99% and 89%, respectively. Procedure-related complications occurred in 10 (12%) patients, of which 1 was procedure-related death. In-hospital mortality was 11%. CONCLUSION: ETDN in patients with necrotizing pancreatitis and infected necrosis performed in a single, high-volume center has an acceptable safety profile and is associated with a low mortality.

EUS-guided transcolonic drainage and necrosectomy in walled-off necrosis: a retrospective, single-center case series.

Background and study aims Transgastric endoscopic ultrasound (EUS)-guided drainage and, if needed, necrosectomy is the preferred treatment in patients with pancreatic walled-off necrosis. EUS-guided transcolonic or transrectal drainage and necrosectomy may serve as a minimally invasive alternative in cases in which transgastric or percutaneous drainage is either impossible or fails to secure sufficient drainage. In this paper, we retrospectively evaluated the feasibility, safety, and efficacy of the treatment. We included nine patients and found a technical success rate of 100%, clinical success in 89%, and one adverse event (11%). Transrectal/transcolonic endoscopic necrosectomy was needed in seven patients (78%).

Simultaneous endoscopic and video-assisted retroperitoneal debridement in walled-off pancreatic necrosis using a laparoscopic access platform: Two case reports.

BACKGROUND: Infected walled-off necrosis is a potentially life-threatening complication of necrotizing pancreatitis. While some patients can be treated by drainage alone, many patients also need evacuation of the infected debris. Central necroses in relation to the pancreatic bed are easily reached via an endoscopic transluminal approach, whereas necroses that involve the paracolic gutters and the pelvis are most efficiently treated via a percutaneous approach. Large and complex necroses may need a combination of the two methods. CASE SUMMARY: Transluminal and percutaneous drainage followed by simultaneous endoscopic and modified video-assisted retroperitoneal debridement was carried out in two patients with very large (32-38 cm), infected walled-off necroses using a laparoscopic access platform. After 34 d and 86 d and a total of 9 and 14 procedures, respectively, complete regression of the walled-off necroses was achieved. The laparoscopic access platform improved both access to the cavities as well as the overview. Simultaneous transluminal and percutaneous necrosectomy are feasible with the laparoscopic access platform serving as a useful adjunctive. CONCLUSION: This approach may be necessary to control infection and achieve regression in some patients with complex collections.

[Endoscopic transduodenal removal of gallbladder stones in a patient with necrotizing pancreatitis].

This case report describes a 55-year-old man with gallstone-induced necrotizing pancreatitis, colonic fistula and subsequent acute cholecystitis. Due to hostile abdominal milieu, traditional cholecystectomy was not possible, why endoscopic ultrasound (EUS)-guided transduodenal drainage of the gallbladder and endoscopic stone extraction was performed successfully. EUS-guided transduodenal drainage of the gallbladder with endoscopic removal of stones constitutes a safe alternative for patients who have cholecystitis, which is not suitable for cholecystectomy.

Short- and Long-Term Outcomes After Multimodal Treatment of Pancreatic Duct Leakage in Patients With Chronic Pancreatitis.

OBJECTIVES: In patients with chronic pancreatitis, pancreatic duct leakage is associated with a prolonged disease course and serious complications. We aimed to assess the efficacy of this multimodal treatment of pancreatic duct leakage. METHODS: In a retrospective design, patients with chronic pancreatitis, an amylase content greater than 200 U/L in either ascites or pleural fluid and treated between 2011 and 2020, were evaluated. The primary end point was treatment success. RESULTS: Twenty-seven patients (22 males, median age 60, median American Society of Anesthesiologists score 3) were included.Endoscopic retrograde pancreatography was performed in 23 patients (85%) with transpapillary stenting of the main pancreatic duct in 22 patients (96%). Pancreatic sphincterotomy and dilation of the main pancreatic duct were done in 14 patients (61%) and 17 patients (74%), respectively. Twelve patients (44%) were treated with somatostatin analogs, parenteral nutrition, and were "nil by mouth" for a median of 11 days (range, 4-34 days). Six patients (22%) had extracorporeal shock wave lithotripsy due to pancreatic duct stones. One patient (4%) was referred for surgery. All 23 patients (100%) were treated with success after a median of 21 days (range, 5-80 days). CONCLUSIONS: Multimodal treatment of pancreatic duct leakage is effective, with minimal need for surgery.

[Videoscopic-assisted retroperitoneal debridement ofnecrotising pancreatitis].

Acute necrotising pancreatitis is a condition associated with high morbidity and mortality, and for decades surgical intervention was the gold standard for treatment of symptomatic pancreatic necrosis. A shift towards minimally invasive interventions has reduced the mortality significantly as summarised in this review. Studies comparing open necrosectomy with videoscopic-assisted retroperitoneal debridement (VARD) have demonstrated that VARD lowers morbidity and mortality. When endoscopic therapy is impossible, VARD is recommended as the preferred surgical intervention for symptomatic necrotising pancreatitis.

Endoscopic treatment with transmural drainage and necrosectomy for walled-off necrosis provides favourable long-term outcomes on pancreatic function.

BACKGROUND AND AIMS: Several studies have shown improved short-term outcome with endoscopic transmural drainage and necrosectomy for the treatment of walled-off pancreatic necrosis. However, knowledge on the long-term prognosis after such treatment is limited. The aim of present study was to evaluate long-term outcomes in patients endoscopically treated with transmural drainage and necrosectomy. METHODS: We retrospectively follow up 125 patients with walled-off pancreatic necrosis treated with endoscopic transmural drainage and necrosectomy in 2010-2017. All patients received plastic pigtail stents and nasocystic catheter. Additional external drainage was performed in 41 patients. Main outcomes were survival, pancreatic function, development of co-morbidities, ability to work and social status. RESULTS: During a median follow-up of 4.3 years, nine (7%) patients died. Seven deaths were unrelated to pancreatic disease, and two patients died of pancreatic cancer. Twenty-two (18%) patients developed exocrine pancreatic insufficiency. Thirty-six (32%) previous non-diabetics developed endocrine insufficiency. Endoscopic necrosectomy during admission (odds ratio (OR) = 1.28, 95% confidence interval (CI) 1.05-1.56; p = 0.015) and therapy on the main pancreatic duct (OR = 8.08, 95% CI 2.43-26.9; p < 0.001) during follow-up predicted development of exocrine insufficiency. Severity on computed tomography predicted endocrine insufficiency (OR = 1.61, 95% CI 1.24-2.09; p < 0.001). Most patients regained their working capacity and preserved their marital status. CONCLUSIONS: This study provides robust data on the long-term outcome of patients with walled-off pancreatic necrosis treated with endoscopic transmural drainage and necrosectomy. The favourable outcomes on survival, pancreatic function and social status support current recommendations of endoscopic transmural drainage and necrosectomy being the treatment of choice for walled-off pancreatic necrosis.

Energy expenditure and loss of muscle and fat mass in patients with walled-off pancreatic necrosis: A prospective study.

OBJECTIVE: Ensuring adequate nutritional support in patients with walled-off pancreatic necrosis (WON) is challenging and weight loss is often considerable. The aim of this study was to evaluate resting energy expenditure (REE) and body composition in patients with WON. METHODS: We prospectively included 18 patients (67% men; median age 63 y; 44% gallstones; 39% alcohol) with WON undergoing endoscopic transgastric drainage and necrosectomy. Patients were followed for 4 wk after admission. We assessed hand-grip strength, REE using indirect calorimetry, and body composition with dual-energy x-ray absorptiometry to assess the percentage change in muscle mass (MM) and fat mass (FM). Data are summarized using medians (range). RESULTS: At baseline, the median body mass index was 27.9 kg/m2 (17.7-35.6 kg/m2). Fifteen patients (83%) had infected WON. Eight patients (44%) received total or supplemental parenteral nutrition. The median percentage loss in MM was 0.31% and FM was 6.2%. The median REE was 6870 kJ (3255-8870 kJ) at baseline. Compared with the predicted REE, the measured REE was 1049 kJ higher (-3065 to 2126 kJ) at baseline and -951 kJ lower (-2600 to 3202 kJ) at 4 wk. The difference between the predicted and measured REE at baseline was correlated with the percentage loss in MM (P = 0.043) and FM (P = 0.026). Additionally, patients with infected WON had significantly higher REE (P = 0.003). CONCLUSION: In patients with WON, an increased REE appears to predict increased muscle and fat loss. Additional studies are necessary to evaluate if REE may be used to improve nutritional support.

[Endoscopic ultrasound-guided establishment of transmural anastomoses in the upper gastrointestinal tract].

The development of endoscopic ultrasound and lumen-apposing metal stents has resulted in novel therapeutic opportunities with the possibility of establishing a persistent transmural anastomosis for the treatment of multiple gastrointestinal disorders. This review presents the applications and the evidence of endoscopic ultrasound and lumen-apposing metal stents. The modality is an alternative for several upper gastrointestinal disorders. Further research and future technological development will show the final position of this therapy in the current treatment algorithm.